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Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia

January 7, 2021

Overview

The Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia study aims to test the effectiveness of the drug zolpidem for treating insomnia. 

 

Study Information 

The study will be divided into three phases. All participants will take zolpidem nightly for one month. If the patient responds to treatment, they will continue with the study and will be assigned to a category: intermittent dosing, which involves taking 3-5 pills a week at full dose, or one of three variable dose categories, which involves taking a pill nightly at a variable dose. 

 

Standard treatment will be 4 weeks while a subsequent experimental phase will last for two periods: one of 12 weeks and another of 36 weeks. This experimental phase will involve changing drug dosages, completing a daily sleep diary, filling out questionnaires and receiving the next dose of medication. 

 

The final stages of the study will involve a physical examination. 

 

Inclusion Criteria

 

  • Has chronic insomnia and meets DSM-5 criteria for Insomnia Disorder, ICSD-3, and RDC criteria for Psychophysiologic Insomnia. 
  • Must take 30 minutes or longer to fall asleep or have 30-minute awake periods during the night, for at least three times per week.

 

Exclusion Criteria

 

  • Currently being treated for insomnia
  • Has unsuccessfully attempted treatment with zolpidem in the past 
  • Has stopped taking zolpidem in the past due to side effects
  • Has any history of parasomnias within the last 5 years

 

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

 

Sponsors / Collaborators

University of Pennsylvania

National Institutes of Health (NIH)

National Institute on Aging (NIA)

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